1. CURRICULUM VITAE
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Work Experience:
1. Bayer Pharmaceuticals Pvt.Ltd (From 01/Aug/2014- Present) as Regulatory Affairs Senior Executive
1. Handling drug Regulatory dossiers for India, Nepal, Sri Lanka and Bangladesh.
2.Co-ordinating regulatory submission for new product registrations, timely product renewals, New site
registration, Import License Application, Post approval variations submission, Communication of critical
updates to DCGI, CDSCO, New Delhi, India for quality and compliance.
3. Liaisoning with Health Authorities and Local FDA’s.
4.Maintenance of Registration Certificate and import License of existing portfolio.
5.Familiar with “SUGAM” online portal at CDSCO for registration Certificate, Import License, Test License
and Post approval changes.
6.To create and maintain the artworks as per the current regulation.
7.Review of Module 3 to ensure the smooth submission to regulatory Authority.
8.To maintain import license for Medical Devices.
9.Co-ordination for the submission of the documents for Medical Devices.
10. To maintain the post-approval variation for Medical Devices.
11. To maintain Registration certificate, import license for all the Biological products.
12. To submit the post approval variations for Biological as per Guidance for Industry.
13. To maintain and keep update regulatory database.
14. Submission of CMC and CCDS variations to the country regulatory authority in eCTD format.
15. To respond to the query by the respective health authorities.
16. To submit PSUR with in the given timeline, Drug Safety related information to regulatory
Authorities.
17. Maintenance and Archival of regulatory documents.
18. Knowledge of CMC data for Regulatory Submission.
19. Interacting with the oversea colleague and accountable for cross-country and cross functional
Activities i.e. Business colleagues, Medical, Marketing, Quality Assurance.
20. Familiar with drug laws, guidelines and timelines issued by the drug authorities of India, Sri
Lanka, Nepal and Bangladesh.
21. To carry out Regulatory Assessment for New Product Registration.
22. Regulatory support for Tender Business
23. Local FDA RA activities like co-ordination with Local FDA and third parties for CoPP, Free sale
certificate and Non conviction certificate and other relevant documents.
24. Co-ordination with Business Development Team.
25. Follow up with manufacturing unit for the CMC documentation.
Present address: Flat No.404 Raj Ratan Park, Bramhand, Thane (W)-♦
400607.
Permanent address: 63, Mahakali nagar, Manewada road,Nagpur-
4440024
Mobile No.: 09975778218
Mr. MANGESH GHANSHAMRAO ITANKAR
CARRER OBJECTIVE
Intend to build a career with Regulatory Affairs which will help to explore my potential and contribute to the
organization. I am willing to work as a key player in challenging and creative environment with positive and
learning attitude.

2. CURRICULUM VITAE
2. Wockhardt Ltd. Aurangabad (From 03/Feb/2014 to 31/Jul/2014) as Quality Assurance Executive:
1. Preparation and review of Annual product Review
2. Preparation of Master BMR/BPR
3. Execution of Validation Activity/Preparation of Validation protocol and report
4. Compilation of process validation reports for CMC dossier
3. Tevapharma India Pvt.Ltd.Goa (From 09/April/2012 to 31/Jan/2014) as Quality Assurance Executive:
1. Handling of Change Control through the Track wise system
2. Handling of Deviation, Out of Specification and Out of trend Results
3. To carry out the process validation
4. Prepare validation protocol and validation report
5. Shop floor Quality Assurance Activity
6. To prepare stability protocol and to compile the stability report
7. Support large-scale operations with quality assurance practices.
8. To perform the documentation required for the Technology Transfer department.
9. To prepare Feasibility study for Successful Transfer of formulation (Site Transfer or R&D Transfer).
10. To prepare Technology Transfer Protocol and Report.
11. Preparation of Stability protocol for Exhibit batches or for the Validation.
12. Timely completion of Technology Transfer report after the successful completion of project.
13. To coordinate with Technology Transfer department for required documentation for submission of
product to the specific countries like Europe, Canada and Japan.
14. Submission of Change to the respective country RA.
4. Inventia Health Care Pvt.Ltd. Mumbai. (From 19/July/2010 to 09/November/2011)
1. Execution of process development experiments and process optimization of formulations.
2.Scale-up of formulations from lab scale to pilot/commercial scale, execution of submission batches and
validation.
3. Preparation & review of batch documents, protocols.
4. Preparation and review of Technology Transfer Protocol and report.
5. To coordinate and execute Trial/ Pre Exhibit / Exhibit / Validation batches as per quality system.
6. Preparation, Review and approval (as and when required) of Master Documents.
7.To plan and coordinate with Production, QA, QC and RA for effective technology transfer (Site transfer
and R&D transfers) as per the master transfer plan.
8.Execution of Trial / Pre Exhibit /Exhibit / Validation batches as per the master transfer plan in
coordination with Production, QA, QC, RA, etc.
9.To carry out IQ, OQ and PQ of new equipment.
Educational Details:

3. CURRICULUM VITAE
Qualification College/University Passing Year Percentage
M. Pharmacy Hon’ble L. M. C College of Pharmacy, Faizpur
North Maharashtra University
2010 65.25%
B. Pharmacy
Jahulal Chaturvedi College of pharmacy
(Nagpur Universitiy)
2008 67.85%
Achievement: Sucessfully faces MHRA and US FDA audits in Inventia Healthcare, Mumbai.
Technical Skills:
MS office, Excel, Power point, Trackwise and SAP.
Mangesh G. Itankar
Contact No.:09975778218